Osteoarthritis, KneeNCT03075319
Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty
A study testing Received perioperative photograph and Didn't receive perioperative photograph in people with Osteoarthritis, Knee, run by Thammasat University.
Trial summary
Total knee arthroplasty (TKA) is recognized as a successful procedure for treating osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the degree of knee flexion. Read more about this study
- Who is it for?
- Ages 55 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Received perioperative photograph and Didn't receive perioperative photograph
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2015to 29 Feb 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.
Who cannot join
- Knee range of motion less than 90 degrees
- Psychotic disorders
- History of stroke
- Inability to undergo a spinal block
About this study
Official title: Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty: Randomized Controlled Trial
Total knee arthroplasty (TKA) is recognized as a successful procedure for treating osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the degree of knee flexion. Providing more range of motion after TKA impact on the convenience of daily of life such as climbing stairs, sitting on the floor particularly in Asian cultures which require a lot of ground activities. Data are limited on the added benefits of perioperative photograph as motivation for increasing range of motion after TKA.
Half of participants received perioperative photograph as motivation, while the other half did not after total knee arthroplasty.
Read the detailed description
All participants received spinal anesthesia, multimodal local anesthetic infiltration and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical techniques, postoperative medications and rehabilitation protocols were identical in both groups. Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken and were given to experimental group in the day after surgery. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. The outcome assessors were blinded to treatment groups during the study period.
- Conditions
- Osteoarthritis, Knee
- Being tested
- Received perioperative photograph, Didn't receive perioperative photograph
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Received perioperative photographProcedure or surgery
All participants in experimental group were adviced to see periopertive knee photograph before rehabilitation everyday.
Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer.
The outcome assessors were blinded to treatment groups.
Didn't receive perioperative photographProcedure or surgery
All participants in active comparator group didn't receive perioperative knee photograph.
Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer.
The outcome assessors were blinded to treatment groups.
| Study group | Role | What they receive |
|---|---|---|
| Received perioperative photograph | Experimental | Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken and gave to experimental group in the day after surgery. Receives: Procedure: Received perioperative photograph |
| Didn't receive perioperative photograph | Active comparator | Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken but participants in this group didn't receive perioperative photographs. Receives: Procedure: Didn't receive perioperative photograph |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knee range of motion
Compare flexion and extension angle using long arm goniometer between experimental and active comparator group
Measured: Flexion and extension angle at 6 month
Secondary outcomes (1)
Knee society scores
Measured: 6 week, 3 month and 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2017
- Study start1 Mar 2015
- Primary completion29 Feb 2016
- Study completion29 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Osteoarthritis, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Thammasat University
- Sponsor type
- University, hospital or other
- Collaborators
- Boontanapibul, Krit, M.D.
- Responsible party
- Principal investigator, piya pinsornsak, Thammasat University
- Investigators
- Piya Pinsornsak, Principal investigator, Faculty of Medicine, Thammasat university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03075319
- Sponsor's protocol ID
- MTU-EC-OT-6-049/56
- Status last verified
- Mar 2017
- First submitted
- 4 Mar 2017
- Last updated
- 13 Mar 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ritter MA, Campbell ED. Effect of range of motion on the success of a total knee arthroplasty. J Arthroplasty. 1987;2(2):95-7. doi: 10.1016/s0883-5403(87)80015-3.
PubMed 3612145Miner AL, Lingard EA, Wright EA, Sledge CB, Katz JN; Kinemax Outcomes Group. Knee range of motion after total knee arthroplasty: how important is this as an outcome measure? J Arthroplasty. 2003 Apr;18(3):286-94. doi: 10.1054/arth.2003.50046.
PubMed 12728419Meneghini RM, Pierson JL, Bagsby D, Ziemba-Davis M, Berend ME, Ritter MA. Is there a functional benefit to obtaining high flexion after total knee arthroplasty? J Arthroplasty. 2007 Sep;22(6 Suppl 2):43-6. doi: 10.1016/j.arth.2007.03.011. Epub 2007 Jul 26.
PubMed 17823014Kurosaka M, Yoshiya S, Mizuno K, Yamamoto T. Maximizing flexion after total knee arthroplasty: the need and the pitfalls. J Arthroplasty. 2002 Jun;17(4 Suppl 1):59-62. doi: 10.1054/arth.2002.32688.
PubMed 12068407Fisher DA, Dierckman B, Watts MR, Davis K. Looks good but feels bad: factors that contribute to poor results after total knee arthroplasty. J Arthroplasty. 2007 Sep;22(6 Suppl 2):39-42. doi: 10.1016/j.arth.2007.04.011. Epub 2007 Jul 26.
PubMed 17823013Harvey IA, Barry K, Kirby SP, Johnson R, Elloy MA. Factors affecting the range of movement of total knee arthroplasty. J Bone Joint Surg Br. 1993 Nov;75(6):950-5. doi: 10.1302/0301-620X.75B6.8245090.
PubMed 8245090Ritter MA, Harty LD, Davis KE, Meding JB, Berend ME. Predicting range of motion after total knee arthroplasty. Clustering, log-linear regression, and regression tree analysis. J Bone Joint Surg Am. 2003 Jul;85(7):1278-85. doi: 10.2106/00004623-200307000-00014.
PubMed 12851353Dennis DA, Komistek RD, Stiehl JB, Walker SA, Dennis KN. Range of motion after total knee arthroplasty: the effect of implant design and weight-bearing conditions. J Arthroplasty. 1998 Oct;13(7):748-52. doi: 10.1016/s0883-5403(98)90025-0.
PubMed 9802659Sharma L, Sinacore J, Daugherty C, Kuesis DT, Stulberg SD, Lewis M, Baumann G, Chang RW. Prognostic factors for functional outcome of total knee replacement: a prospective study. J Gerontol A Biol Sci Med Sci. 1996 Jul;51(4):M152-7. doi: 10.1093/gerona/51a.4.m152.
PubMed 8680997Bonnin M, Laurent JR, Parratte S, Zadegan F, Badet R, Bissery A. Can patients really do sport after TKA? Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):853-62. doi: 10.1007/s00167-009-1009-4. Epub 2009 Dec 24.
PubMed 20033676Naylor JM, Ko V, Adie S, Gaskin C, Walker R, Harris IA, Mittal R. Validity and reliability of using photography for measuring knee range of motion: a methodological study. BMC Musculoskelet Disord. 2011 Apr 18;12:77. doi: 10.1186/1471-2474-12-77.
PubMed 21496347Gogia PP, Braatz JH, Rose SJ, Norton BJ. Reliability and validity of goniometric measurements at the knee. Phys Ther. 1987 Feb;67(2):192-5. doi: 10.1093/ptj/67.2.192.
PubMed 3809242
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Perioperative Photograph as a Motivation for Increasing Range of Motion After Primary Total Knee Arthroplasty: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03075319
- Acronym / sponsor ID
- MTU-EC-OT-6-049/56
- Conditions
- Osteoarthritis, Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Thammasat UniversityUniversity, hospital or other
- Collaborators
- Boontanapibul, Krit, M.D.
- Study start
- 1 Mar 2015 (actual)
- Primary completion
- 29 Feb 2016 (actual)
- Study completion
- 29 Feb 2016 (actual)
- First posted
- 9 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total knee arthroplasty (TKA) is recognized as a successful procedure for treating osteoarthritis (OA) of the knee. One important factor that make the successful surgery is the degree of knee flexion. Providing more range of motion after TKA impact on the convenience of daily of life such as climbing stairs, sitting on the floor particularly in Asian cultures which require a lot of ground activities. Data are limited on the added benefits of perioperative photograph as motivation for increasing range of motion after TKA.
Half of participants received perioperative photograph as motivation, while the other half did not after total knee arthroplasty.
Detailed description
All participants received spinal anesthesia, multimodal local anesthetic infiltration and patient controlled analgesia (PCA) for 24 hours post surgery. The surgical techniques, postoperative medications and rehabilitation protocols were identical in both groups. Perioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken and were given to experimental group in the day after surgery. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. The outcome assessors were blinded to treatment groups during the study period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Received perioperative photograph | Experimental | Procedure: Received perioperative photographPerioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken and gave to experimental group in the day after surgery. |
| Didn't receive perioperative photograph | Active comparator | Procedure: Didn't receive perioperative photographPerioperative knee range of motion (ROM) were measured with long arm goniometer immediately after close the wound. Perioperative knee photographs in full flexion and extension positions were taken but participants in this group didn't receive perioperative photographs. |
Who may qualify
- Ages
- 55 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Primary OA of the knee, aged less than 80 years old, and able to understand and comply with the study procedures.
Key exclusion criteria (4 listed)
- Knee range of motion less than 90 degrees
- Psychotic disorders
- History of stroke
- Inability to undergo a spinal block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Received perioperative photographAll participants in experimental group were adviced to see periopertive knee photograph before rehabilitation everyday. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer. The outcome assessors were blinded to treatment groups. | Procedure or surgery | Received perioperative photograph |
| Didn't receive perioperative photographAll participants in active comparator group didn't receive perioperative knee photograph. Postoperative knee ROM were recorded at day 3, 6 week, 3 month and 6 month. Flexion and extension angle were measured with long arm goniometer. The outcome assessors were blinded to treatment groups. | Procedure or surgery | Didn't receive perioperative photograph |
Primary outcome
Knee range of motion
Time frame: Flexion and extension angle at 6 month
Compare flexion and extension angle using long arm goniometer between experimental and active comparator group
1 secondary outcome
Knee society scores
Time frame: 6 week, 3 month and 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2017.
- Results publication: PubMed 3612145Ritter MA, Campbell ED. Effect of range of motion on the success of a total knee arthroplasty. J Arthroplasty. 1987;2(2):95-7. doi: 10.1016/s0883-5403(87)80015-3.
- Results publication: PubMed 12728419Miner AL, Lingard EA, Wright EA, Sledge CB, Katz JN; Kinemax Outcomes Group. Knee range of motion after total knee arthroplasty: how important is this as an outcome measure? J Arthroplasty. 2003 Apr;18(3):286-94. doi: 10.1054/arth.2003.50046.
- Results publication: PubMed 17823014Meneghini RM, Pierson JL, Bagsby D, Ziemba-Davis M, Berend ME, Ritter MA. Is there a functional benefit to obtaining high flexion after total knee arthroplasty? J Arthroplasty. 2007 Sep;22(6 Suppl 2):43-6. doi: 10.1016/j.arth.2007.03.011. Epub 2007 Jul 26.
- Results publication: PubMed 12068407Kurosaka M, Yoshiya S, Mizuno K, Yamamoto T. Maximizing flexion after total knee arthroplasty: the need and the pitfalls. J Arthroplasty. 2002 Jun;17(4 Suppl 1):59-62. doi: 10.1054/arth.2002.32688.
- Results publication: PubMed 17823013Fisher DA, Dierckman B, Watts MR, Davis K. Looks good but feels bad: factors that contribute to poor results after total knee arthroplasty. J Arthroplasty. 2007 Sep;22(6 Suppl 2):39-42. doi: 10.1016/j.arth.2007.04.011. Epub 2007 Jul 26.
- Results publication: PubMed 8245090Harvey IA, Barry K, Kirby SP, Johnson R, Elloy MA. Factors affecting the range of movement of total knee arthroplasty. J Bone Joint Surg Br. 1993 Nov;75(6):950-5. doi: 10.1302/0301-620X.75B6.8245090.
- Results publication: PubMed 12851353Ritter MA, Harty LD, Davis KE, Meding JB, Berend ME. Predicting range of motion after total knee arthroplasty. Clustering, log-linear regression, and regression tree analysis. J Bone Joint Surg Am. 2003 Jul;85(7):1278-85. doi: 10.2106/00004623-200307000-00014.
- Results publication: PubMed 9802659Dennis DA, Komistek RD, Stiehl JB, Walker SA, Dennis KN. Range of motion after total knee arthroplasty: the effect of implant design and weight-bearing conditions. J Arthroplasty. 1998 Oct;13(7):748-52. doi: 10.1016/s0883-5403(98)90025-0.
- Results publication: PubMed 8680997Sharma L, Sinacore J, Daugherty C, Kuesis DT, Stulberg SD, Lewis M, Baumann G, Chang RW. Prognostic factors for functional outcome of total knee replacement: a prospective study. J Gerontol A Biol Sci Med Sci. 1996 Jul;51(4):M152-7. doi: 10.1093/gerona/51a.4.m152.
- Results publication: PubMed 20033676Bonnin M, Laurent JR, Parratte S, Zadegan F, Badet R, Bissery A. Can patients really do sport after TKA? Knee Surg Sports Traumatol Arthrosc. 2010 Jul;18(7):853-62. doi: 10.1007/s00167-009-1009-4. Epub 2009 Dec 24.
- Results publication: PubMed 21496347Naylor JM, Ko V, Adie S, Gaskin C, Walker R, Harris IA, Mittal R. Validity and reliability of using photography for measuring knee range of motion: a methodological study. BMC Musculoskelet Disord. 2011 Apr 18;12:77. doi: 10.1186/1471-2474-12-77.
- Results publication: PubMed 3809242Gogia PP, Braatz JH, Rose SJ, Norton BJ. Reliability and validity of goniometric measurements at the knee. Phys Ther. 1987 Feb;67(2):192-5. doi: 10.1093/ptj/67.2.192.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Piya Pinsornsak principal investigator
Faculty of Medicine, Thammasat university
Questions about this trial
What is this clinical trial studying?
A study testing Received perioperative photograph and Didn't receive perioperative photograph in people with Osteoarthritis, Knee, run by Thammasat University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knee range of motion (time frame: Flexion and extension angle at 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03075319, which also lists 12 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2017.